EN

  • How to classify and obtain CE mark and FDA clearance of standalone medical device software
  • Applying IEC 62304 requirements to software development cycle
  • IEC 62304 advanced and application to agile methods
  • Risk management in software medical devices
  • La Matériovigilance dans les Dispositifs Médicaux
  • Management de la Qualité dans les Dispositifs Médicaux et marquage CE
  • Management des processus
  • Informations pratiques
  • How to classify and obtain CE mark and FDA clearance of standalone medical device software

    With emerging technologies like mobile Health (mHealth), intelligent or communicating devices, software undertakes a large part of functionalities of most recent devices. Many firms feel that they are not prepared to have their processes about software audited by regulatory agencies.

    Software is incredibly more present in medical devices now than 5 to 10 years ago. The path to get the CE Mark or FDA clearance for software medical devices can be long. It can also dramatically be shortened with the right decisions and good information.

    Knowing the key steps and the pitfalls in your way to obtain the CE Mark is a factor of success for medical devices start-ups.

    Duration: 1 day

    Whom is this training for?

    People working for medical devices or in vitro diagnosis manufacturers:

    • CTO or CEO of start-ups,
    • Quality Assurance and Regulatory Affairs Managers,
    • Software Project Managers,
    • Software Development, Risk Management, and Test Engineers.

     

    Learning Objectives

    • Learn about CE regulatory framework: 93/42 CE directive, CE guidances.
    • Learn about US regulatory framework: 21.CFR, Food and Drug Administration (FDA).
    • Learn harmonized standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 62304 …
    • Learn what activities are required: software design, software maintenance.
    • Learn how the obtain the CE Mark and FDA clearance.

     

    Course Outline

    Introduction,
    Worldwide overview of Regulations,
    The CE Mark and the CE Directives,

    The 21.CFR and FDA regulations,
    Application to software medical devices,
    ISO standards for software medical devices,

    Paths to Clearance and CE mark.

    An example with a software product will be used to illustrate the concepts described during the course.

    Instructor profile

     

    M. Cyrille Michaud is consultant for MD101. See profile

    For more information contact us at: cyrille.michaud@md101consulting.com

    -software

    Applying IEC 62304 requirements to software development cycle

    IEC 62304 is the gold standard of software processes in medical devices. It is a recognized standard by the FDA. The EN version (EN IEC 62304) is a harmonized standard for CE Mark.

    Achieving efficient best practice through application IEC 62304 is the path to success of software in your medical devices. Software is incredibly more present now in medical devices than 5 to 10 years ago. With emerging technologies like mobile Health (mHealth), intelligent or communicating devices, software undertakes a large part of functionalities of most recent devices.
    Many firms feel that they are not prepared to have their processes about software audited by regulatory agencies.

    Duration: 1 day

    Whom is this training for?

    People working for medical devices or in vitro diagnosis manufacturers:

    • Quality Assurance and Regulatory Affairs Managers,
    • Software Project Managers,
    • Software Development, Risk Management, and Test Engineers.

     

    Learning Objectives

    • Learn about main goals of the IEC 62304 standard.
    • Learn what IEC 62304 requires throughout the lifecycle of software.
    • Learn how IEC 62304 integrates Risk Management activities.
    • Learn what documents you should write to prove compliance to the standard.

     

    Course Outline

    • Introduction.
    • History of software standards in medical devices.
    • Terms & definitions
    • General Requirements
    • Software Development Process
    • Software Risk Management
    • Software Maintenance

     

    Instructor profile

     

    M. Cyrille Michaud is consultant for MD101. See profile

    For more information contact us at: cyrille.michaud@md101consulting.com

    IEC 62304 advanced and application to agile methods

    Risk management in software medical devices

    La Matériovigilance dans les Dispositifs Médicaux

    Management de la Qualité dans les Dispositifs Médicaux et marquage CE

    Management des processus

    News
    Liens utiles
    md101 - medical devices consulting from france
    Affaires réglementaires 

    Vous avez conçu un produit et utilisé sur le terrain à des fins de recherche clinique ou dans un environnement clinique simulé. Vous êtes désireux d’obtenir les autorisations de placer votre produit sur ​​le marché pour une utilisation clinique réelle.
    Nous vous aidons à passer à travers les phases obligatoires pour obtenir une autorisation de marché aux États-Unis ou en Europe: